Principal Statistician (f / m)

Boehringer Ingelheim

Biberach an der Riss, Germany

Ref: 1814405

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Are you looking for a position that will allow you to continue to work in the pharmaceutical industry? Are you agile, self-motivated, creative and customer-oriented with a proactive mindset and a can-do attitude? Then join our Clinical Statistics group, preferably in Biberach (close to Ulm), Germany.

At Boehringer Ingelheim, responsibility for methodological and operational aspects of statistics in clinical development programs and thereafter is shared by statisticians with different specializations. Within statistics, the focus areas are Translational Medicine and Clinical Pharmacology (TMCP), late phase development and regulatory submissions (both primarily located in Biberach), and medical affairs (primarily located in Ingelheim). For the current open position, we are particularly looking for statisticians with TMCP and / or late phase and regulatory submissions focus areas.

Tasks & responsibilities

  • Responsibility for all statistical aspects of complex Phase I-IV clinical trial and / or statistical support or lead of global clinical development projects.
  • Planning, coordination, prioritization and implementation of statistical aspects of
    • biomarker-guided clinical development, pharmacogenomics, pharmacokinetics (PK), pharmacodynamics (PD), ECG and dose finding and / or
    • clinical development in Phase IIb, III and regulatory submissions
  • Application of established and innovative statistical methodology in clinical trials and projects, including design of innovative studies, development of quantitative milestones (eg Go / No Go criteria) and statistical-methodological input into alternative project development scenarios.
  • Efficient, innovative, and robust drug development processes.
  • Collaboration with and on a statistical team as well as on a trial basis.

Requirements

  • Master and / or Doctoral Degree in Statistics or Mathematics
  • At least six years of experience working as a trial and statistician in clinical development, in the pharmaceutical industry
  • Thorough understanding of pharmaceutical drug development, GCP and regulatory requirements as well as a thorough knowledge of how to process clinical trial information and a proven track record in planning clinical trials and projects
  • Thorough knowledge of contemporary statistical methodology, including adaptive designs, Bayesian methodology, causal inference. Special knowledge of mediation analysis, trial simulation and data visualization would be an advantage
  • Subject matter knowledge of and proven track record of achievements in
    • analysis of PK / PD data as well as different types of biomarker data and related technologies / assays for measurement and / or
    • regulatory interactions as well as planning and regulatory submission
  • Substantiated knowledge in applying statistical software solutions. SAS and R is a must
  • Good project management skills and excellent communication and presentation skills
  • Fluency in written and spoken English

Our benefits

  • Good work and private life
  • Flex-time and working remotely
  • Good development opportunities with in-house education and various training options
  • Personal mentoring in onboarding
  • Competitive salary plus bonus payments

Who are we

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals.As a family owned company we focus on long term performance. We are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because of your growth is our growth.Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
We look forward to receiving your online application!

Contact

For further information please contact Recruiting Services:Mrs. Denise Schwegler, Tel: +49 (0) 7351 / 54-145528.


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